High Tone Therapy for Chemotherapy Induced Neuropathy

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

High Tone Therapy for Chemotherapy Induced Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06048471
• Other study ID #: HiTop Protocol v.1.3
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: September 22, 2023

Study information

• Verified date: October 2023
• Source: Vienna Hospital Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chemotherapy-induced peripheral neuropathy (CIPN), a side effect of antineoplastic medication, was reported to occur in about 68% of the patients receiving chemotherapy. CIPN does not only limit quality of life due to neuropathic symptoms but also may lead to dose reductions or premature interruption of therapy and thus to suboptimal cancer treatment.

Patients with neuropathy suffer from sensory disturbances as tingling, numbness, burning pain or sleep disturbances and even though numerous drugs are available, it is still difficult to sufficiently control these Symptoms.

High tone therapy / high tone external muscle stimulation (HTEMS) seems to be an effective treatment for neuropathic symptoms. Previous studies observed promising results in diabetics and chronic kidney disease (CKD) patients.

To date, there is no investigation on HTEMS in patients with chemotherapy induced neuropathy.

Therefore, this aim of this project is to test if HTEMS would bring about a stronger decrease in neuropathic symptoms in this specific patient group, compared to a placebo treatment.

The primary objective is the alleviation of paresthesias. The secondary objective focuses on detailed symptoms of neuropathiy as well as on health-related quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients with histologically verified colorectal cancer and adjuvant treatment with a platin derivate (e.g., cisplatin, oxaliplatin): This group was chosen due to relatively high risk of neuropathy due to this special therapeutic agent 1,9.

• Cumulative dose of at least 3 cycles

• Interval of 2 weeks since the last chemotherapeutic cycle in order to prevent false worsenings due to delayed neurotoxic effects

• Life expectancy of at least 3 months

• Stable medication (no changes of especially pain medication during the study)

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (that is, the capability to walk and to spend less than 50% of waking hours sitting or lying)

• Ability to walk (with or without aids)

• European Organisation for Research and Treatment of Cancer (EORTC) common toxicity criteria (CTC) peripheral sensory neuropathy grade 1 or 2

• Intensity of paresthesias of 3/10 or higher on the Numeric Rating Scale (NRS)

Exclusion criteria:

• Prevalent neuropathy of different etiology

• Serious central-neurological or psychiatric disorder that would interfer with a proper order of the study, according to the judgement of the investigators

• Epilepsy

• Minors or persons unable to give informed consent

• Current neurotoxic medication

• Implanted pacemakers or defibrillators

• Pregnancy

• Wounds in the area to be treated, acute local or systemic infection

• Peripheral arterial occlusive disease > grade 2

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Electrical Stimulation
• Peripheral Nervous System Diseases

Intervention

Other:
• HiTop
High tone transcutaneous electrical stimulation

Locations

Country	Name	City	State
Austria	Klinik Donaustadt	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Hospital Association

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of paresthesia	NRS scale	5 weeks
Secondary	health related Quality of life (QOL), detailed symptroms of neuropathy	EORTC C30, CIPN 20, Neuropathy symptom scale (NSS), NRS scales	5 weeks